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CompletedNCT03470090Updated Mar 21, 2018

The Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis

An interventional study of Neuromuscular Exercises and Conventional Group in Exercise and Osteoarthritis, sponsored by Inonu University. Completed at 1 site in Turkey. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-21.

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study summary

This study was planned to evaluate the effect of neuromuscular exercise program on physical activity, functionality and balance in patients with knee osteoarthritis aged 35-65 years.

Read the detailed description

The degeneration that occurs in the osteoarthritis of the knee joint leads to the loss of proprioception, resulting in the misalignment of the mechanoreceptors in that region, the joint stabilization is impaired, the muscles do not fulfill the protective role and the joint neuromuscular is inadequate for control. Neuromuscular control is the subcortical activity of effector structures against stimulation with mechanoreceptor, visual, and vestibular affinities. Proprioception, kinesthesia, sensation of joint position, visual and vestibular information constitute sensory data; functional motor patterns, dynamic joint stability and reactive neuromuscular control motor efferent response definitions. Disturbance of neuromuscular control of the muscles also affects walking and balance with abnormal weight transfer. There are many ways to treat knee osteoarthritis such as patient education, weight control, different physical therapy modalities (hot, cold, electrotherapy, deep heat), exercise, pharmacological treatments (topical, systemic, intraarticular). There is no radical treatment of osteoarthritis to restore structural changes; but with the treatment applied, findings such as pain and loss of function of the individual can be reduced and the patients become more independent in daily life activities. Surgical treatment is the last resort in osteoarthritis. In osteoarthritis( OA), there is no pharmacological method to treat the deformed joint structure that will change the course of the disease. This situation significantly increases the importance of rehabilitation in the treatment of osteoarthritis. The aim of neuromuscular rehabilitation that reestablish and regulated features such as dynamic joint stability, reactive neuromuscular control, functional motor patterns. Rehabilitation programs created for this purpose include balance exercises, strengthening exercises, postural control, functional exercises, postural orientation, flexibility, agility, plyometric exercises, spore-specific exercises. neuromuscular exercise program includes 7 parameters including functional mobility, functional stability, sensorimotor system training, proprioceptive neuromuscular facilitation training techniques, plyometric exercises, reactive neuromuscular system training, technical training. Main purpose of this study is that the effect of neuromuscular exercise program on physical activity, functionality and balance in patients with knee osteoarthritis.

02

Conditions studied

  • Exercise
  • Osteoarthritis

Keywords

  • Physical activity
  • Function
  • Balance
  • Neuromuscular exercises
  • Osteoarthritis
03

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with knee osteoarthritis,
  • individuals without a physical disability,
  • person in an age range 35- 65 years,
  • Having no any knee surgeon,
  • Mentally that is sufficient to make assessments,
  • Who want to be involved voluntary work,
  • Ability to adjust the training program
  • Individuals who received informed consent

Exclusion criteria

Exclusion Criteria:

  • Individuals who do not allow mental evaluation
  • Individuals who do not want to be involved in voluntary work.
  • Clinical study refused to participate in.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Neuromuscular Exercises Group

    This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and neuromuscular exercises training

    Behavioral: Neuromuscular Exercises

  • Active comparator
    Conventional Group

    This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and conventional exercises.

    Behavioral: Conventional Group

Interventions

  • BehavioralNeuromuscular Exercises

    In the experimental group, the subjects who were taken into the study were taken to the neuromuscular exercise (NME) program after the pre-treatment evaluations. The subjects in this group were given classical physiotherapy and NME performed 6 days a week, 1 set of 10 times physiotherapist control. NME was including warming, neuromuscular exercises (balance, muscle strengthening, proprioception, sensorimotor system training, joint stabilization and postural control exercises) and cooling periods.

  • BehavioralConventional Group

    In the control group, the subjects who were taken into the study were taken to the classical physiotherapy (hotpack (HP), ultrasound (US), transcutaneous electrical stimulation (TENS)) and conventional exercises program after the pre-treatment evaluations.

05

What researchers measure

Primary outcomes

  1. Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of patients with knee osteoarthritis at 6 weeks.

    The scale used to measure knee function (0-100 total score). High scores indicate poor function status and low scores indicate good function status. The scale contains 24 questions, three subgroups of pain, stiffness and physical function. There are 5 alternative answers to the questions: 0 = no, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The rating (total of all answers / 96) was calculated as \* 100.

    Time frame: 6 weeks

Secondary outcomes

  1. Changed from Visual Analog Scale (VAS) of patients with knee osteoarthritis at 6 weeks.

    It used to measure level of pain (0-100 mm). On a horizontal line of 100 millimeters (mm), the initial 0 (no pain) and end (pain at unbearable grade) were marked. It was requested to place a mark on this horizontal line according to the degree of pain they felt in the cases. The point marked on the line was then recorded as a VAS value in mm, measured by a ruler.

    Time frame: 6 weeks

  2. Change from International Physical Activity Questionnaire (IPAQ) Short Form of patients with knee osteoarthritis at 6 weeks.

    It used to measure level of physical activity. IPAQ short form; 7 questions that provide information about time spent on walking, moderate to severe activities, and time spent sitting. The energy required for the activities was calculated by the MET-minute score. Standard MET values for these activities are: Walk = 3,3 MET; Moderate Severe Physical Activity = 4,0 MET; Severe Physical Activity = 8.0 MET; Seating = 1,5 MET.

    Time frame: 6 weeks

  3. Change from Y Balance Test of patients with knee osteoarthritis at 6 weeks.

    It used to measure static balance.Anterior (A), Posteromedial (PM) and posterolateral (PL) measurements were performed. It was glued to three graves at 120 degrees. The patient was asked to put one foot on the intersection of these three bombers and to lie in directions A, PM, and PL with the other foot. During the test, the patient was asked to point to the maximum point he could reach without touching his foot and to bring it to the stable foot without losing balance. The distance is measured in centimeters.

    Time frame: 6 weeks

  4. Change from 2000 International Knee Documentation Committee (IKDC) of patients with knee osteoarthritis at 6 weeks.

    It used to measure functionality. The questionnaire consists of 10 questions in total. 0 is the worst level of activity when measuring activity level; 4 is answered for the maximum level of activity. Similarly, when evaluating frequency, 0 is the most severe, 10 is not. 0-100 total score.

    Time frame: 6 weeks

06

Study locations

1 site
  • Malatya Gozde Hospital
    Malatya, 44100, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03470090
Lead sponsor
Inonu University
Responsible party
Burcu Talu (Asistant Professor, Inonu University) — Principal investigator
First posted
Mar 19, 2018
Start date
Jun 1, 2017
Primary completion
Sep 30, 2017
Completion
Dec 16, 2017
Last update
Mar 21, 2018

Study contacts

Burcu Talu, PhD
principal investigator · Inonu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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